FDA — authorised 10 August 2011
- Application: ANDA201885
- Marketing authorisation holder: AM REGENT
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Cyklokapron in United States
FDA authorised Cyklokapron on 10 August 2011 · 253 US adverse-event reports
Marketing authorisations
FDA — authorised 2 March 2012
- Application: ANDA091596
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 December 2012
- Application: ANDA202093
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 June 2013
- Application: ANDA201580
- Marketing authorisation holder: XGEN PHARMS
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 January 2014
- Application: ANDA202286
- Marketing authorisation holder: APOTEX
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2014
- Application: ANDA202436
- Marketing authorisation holder: HERITAGE
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 September 2015
- Application: ANDA205133
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2016
- Application: ANDA205035
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 July 2016
- Application: ANDA203256
- Marketing authorisation holder: ANI PHARMS
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 February 2017
- Application: ANDA207239
- Marketing authorisation holder: GLAND
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2017
- Application: ANDA206713
- Marketing authorisation holder: MICRO LABS
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 July 2017
- Application: ANDA205228
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2019
- Application: NDA212020
- Marketing authorisation holder: EXELA PHARMA
- Local brand name: TRANEXAMIC ACID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 17 July 2019
- Application: ANDA212360
- Marketing authorisation holder: CAPLIN
- Local brand name: TRANEXAMIC ACID
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 2021
- Application: ANDA209860
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
FDA — authorised 23 June 2022
- Application: ANDA091657
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Indication: Labeling
- Status: approved
FDA — authorised 16 April 2024
- Application: ANDA216877
- Marketing authorisation holder: NEXUS
- Local brand name: TRANEXAMIC ACID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 June 2024
- Application: ANDA218320
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 August 2024
- Application: ANDA218242
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: TRANEXAMIC ACID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 2 June 2025
- Application: ANDA218896
- Marketing authorisation holder: HERITAGE
- Local brand name: TRANEXAMIC ACID
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 11 June 2025
- Application: ANDA218729
- Marketing authorisation holder: APPCO
- Local brand name: TRANEXAMIC ACID
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA019281
- Marketing authorisation holder: PFIZER
- Local brand name: Cyklokapron
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 253
Most-reported reactions
- Nausea — 32 reports (12.65%)
- Off Label Use — 28 reports (11.07%)
- Pulmonary Embolism — 28 reports (11.07%)
- Pyrexia — 28 reports (11.07%)
- Fatigue — 26 reports (10.28%)
- Haemorrhage — 24 reports (9.49%)
- Vomiting — 24 reports (9.49%)
- Drug Ineffective — 22 reports (8.7%)
- Febrile Neutropenia — 22 reports (8.7%)
- Dizziness — 19 reports (7.51%)
Cyklokapron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Cyklokapron approved in United States?
Yes. FDA authorised it on 10 August 2011; FDA authorised it on 2 March 2012; FDA authorised it on 27 December 2012.
Who is the marketing authorisation holder for Cyklokapron in United States?
AM REGENT holds the US marketing authorisation.